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LAMICTAL (Lamotrigine) For The Treatment Of Absence Seizures

NCT ID: NCT00144872

Last Updated: 2017-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-01

Study Completion Date

2006-04-22

Brief Summary

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This is an open-label study evaluating the efficacy and safety of lamotrigine (LTG) for the treatment of newly-diagnosed typical absence seizures. Subjects will be children and adolescents \< 13 years of age. It will be conducted at multiple sites in the US. The study will consist of 4 phases: Screen Phase (up to 1 week), Baseline Phase (24 hours), Escalation Phase (up to 20 weeks) and Maintenance Phase (12 weeks). Subjects will receive increasing doses of LTG according to the dosing schedule until attaining seizure freedom as confirmed by hyperventilation (HV) for clinical signs and a 1-hr EEG at 2 consecutive weekly visits. At that point, subjects will move into the 12-week Maintenance Phase. Subjects who do not achieve seizure freedom upon reaching the maximum dose (10.2mg/kg/day) with the specified dose escalation will be discontinued from the study. During the Maintenance Phase, the investigators will use their best effort to maintain the subjects at the efficacious dose reached. If the subjects have unacceptable side effects or inadequate seizure control, the doses of study drug can be increased or decreased as specified in the dosing schedule. Safety will be assessed by monitoring adverse events, laboratory assessments, and serum lamotrigine levels. Health outcomes assessments will also be conducted.

Detailed Description

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Conditions

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Seizure, Absence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subjects receiving lamotrigine

Eligible subjects will receive chewable dispersible tablets of lamotrigine with a starting dose of 0.3 milligrams per kilogram administered orally.

Group Type EXPERIMENTAL

Lamotrigine

Intervention Type DRUG

Lamotrigine will be given as chewable dispersible tablets with dosing strengths of 2, 5, 25, and 100 milligrams.

Interventions

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Lamotrigine

Lamotrigine will be given as chewable dispersible tablets with dosing strengths of 2, 5, 25, and 100 milligrams.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Newly-diagnosed with absence epilepsy and never been treated with Anti-epileptic drugs (AEDs).
* Diagnosis demonstrated on one of two 5-minute hyperventilation tests.
* Investigator must judge that the subject and parent/guardian are likely to comply with all study procedures.
* Parent/guardian must given written informed consent. Subjects who are intellectually able to understand the concepts and procedures of the protocol must give assent by also signing the consent or by signing a separate assent form.
* Results of all screen assessments are judged to be clinically acceptable to the investigator and do not indicate any reasons why entry into the study would be contraindicated.

Exclusion Criteria

* Seizures are the result of a currently active, known, and identifiable intracerebral lesion.
* Has partial or generalized tonic-clonic seizures.
* Has a progressive neurological disorder defined as being unstable for at least 12 weeks prior to the Screen Phase.
* Has a psychiatric disorder requiring medication, or has had a past psychiatric condition that was both judged to be severe and required hospitalization.
* Has any clinically significant chronic cardiac, renal, or hepatic medical condition.
* Has a condition that affects the absorption, distribution, metabolism, or excretion of drugs.
* Is currently taking any psychoactive drugs to treat hyperactivity disorder or attention deficit disorder.
* Has taken any investigational drug within 12 weeks prior to the Screen Phase.
* Is sexually active.
* Is either pregnant (i.e., confirmed by pregnancy test at Screen) or breastfeeding.
* Has a clinically significant chronic medical disorder which the investigator and/or GSK medical monitor determine warrants exclusion.
Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

San Jose, California, United States

Site Status

GSK Investigational Site

Loxahatchee Groves, Florida, United States

Site Status

GSK Investigational Site

Melbourne, Florida, United States

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GSK Investigational Site

Panama City, Florida, United States

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GSK Investigational Site

Tallahassee, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Louisville, Kentucky, United States

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Springfield, Missouri, United States

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Newark, New Jersey, United States

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Buffalo, New York, United States

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Rochester, New York, United States

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Chapel Hill, North Carolina, United States

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Greenville, North Carolina, United States

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Raleigh, North Carolina, United States

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Portland, Oregon, United States

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Germantown, Tennessee, United States

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Nashville, Tennessee, United States

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Fort Worth, Texas, United States

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Seattle, Washington, United States

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GSK Investigational Site

Madison, Wisconsin, United States

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GSK Investigational Site

Milwaukee, Wisconsin, United States

Site Status

GSK Investigational Site

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Holmes GL, Frank LM, Sheth RD, Philbrook B, Wooten JD, Vuong A, Kerls S, Hammer AE, Messenheimer J. Lamotrigine monotherapy for newly diagnosed typical absence seizures in children. Epilepsy Res. 2008 Dec;82(2-3):124-32. doi: 10.1016/j.eplepsyres.2008.07.016. Epub 2008 Sep 7.

Reference Type DERIVED
PMID: 18778916 (View on PubMed)

Study Documents

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Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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LAM100118

Identifier Type: -

Identifier Source: org_study_id